PERIACTIVE- sambucus nigra flower, echinacea purpurea, and centella asiatica mouthwash
Izun Pharmaceutical Corporation

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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PeriActive ®

Drug Facts:

Active Ingredients (in each 15ml)	Purposes
Sambucus nigra 3x	Irritation/gingivitis reducer gum repair stimulator
Echinacea purpurea 4x	Irritation/gingivitis reducer
Hydrocotyle asiatica 4x	Irritation/gingivitis reducer

Uses

Helps protect against gingivitis
Helps reduce gum bleeding and soreness
Helps reduce plaque formation
Helps reduce gum inflammation
Promotes gingival healing

Warnings

Allergy alert

Do not use if allergic to any of the ingredients. Stop use and ask a dentist if:

gingivitis, bleeding, or redness persists for more than 2 weeks
you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be the signs of periodontitis, a serious form of gum disease.

Keep out of reach of children under 6 years of age.

In case more than is used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years and older	rinse for 60 seconds with 15ml (3 teaspoonful) twice a day
children 6-12 years	rinse for 60 seconds with 10ml (2 teaspoonful) twice a day
children under 6 years of age	do not use

do not eat, drink or rinse your mouth for 30 minutes after use
do not swallow
children 6 years to under 12 years of age: supervise use

Other information

This rinse is not intended to replace brushing or flossing

store at room temperature 15-30°C (59-86°F)
keep out of direct sunlight
do not use if tab is broken, breached or missing

Inactive ingredients

cetylpyridinium chloride, cool mint flavor 1, disodium EDTA, FD&C Blue No. 1 ,lactic acid, maltodextrin, menthol, nat. cinnamon flavor 1, PEG-40 hydrogenated castor oil, propylene glycol, sodium benzoate, sorbitol, sucralose, water, wintergreen flavor 1

1: contains one or more of these ingredients

Questions?

Call 1-877-210-2621 Monday thru Friday 8am-5pm EST

Distributed by: Izun Oral Care, Inc., New York, NY 10020 USA

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

PeriACTIVE ®

ADVANCED GUM CARE

ORAL RINSE

CLINICALLY PROVEN
to Reduce Inflammation

KILLS BACTERIA

REDUCES
Gum Bleeding & Soreness

PROTECTS
Against Plaque & Gingivitis

Fresh Mint

HOMEOPATHIC

Safety-sealed for your protection.
500 mL (16.9 fl. oz.)

Principal Display Panel - 500 mL Bottle Label

PERIACTIVE
sambucus nigra flower, echinacea purpurea, and centella asiatica mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49589-111
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T) (SAMBUCUS NIGRA FLOWER - UNII:07V4DX094T)	SAMBUCUS NIGRA FLOWER	3 [hp_X] in 1 mL
ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98)	ECHINACEA PURPUREA	4 [hp_X] in 1 mL
CENTELLA ASIATICA (UNII: 7M867G6T1U) (CENTELLA ASIATICA - UNII:7M867G6T1U)	CENTELLA ASIATICA	4 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
EDETATE DISODIUM (UNII: 7FLD91C86K)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:49589-111-50	12 in 1 CARTON	01/11/2009
1		500 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:49589-111-10	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		01/11/2009	12/31/2020

Labeler - Izun Pharmaceutical Corporation (624194523)

Name	Address	ID/FEI	Business Operations
Establishment
LC Beauty		338857935	manufacture(49589-111)

Revised: 9/2021

Document Id: cc0c31a2-5e3d-7af9-e053-2995a90a82d4

Set id: a38b9e40-add9-4551-9d1d-18f049f6e3ba

Version: 8

Effective Time: 20210915

Izun Pharmaceutical Corporation